NCT02936362

Brief Summary

Bread is the most common grain product in the world, with consumption surpassing 3 billion individuals per year. Sourdough whole-grain bread is considered a healthy alternative to white, refined-wheat bread. This cross-over study will test the effect of consumption of sourdough bread compared to white bread following a short dietary intervention period (one week) on multiple clinical parameters and gut microbiota.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 13, 2016

Last Update Submit

October 14, 2016

Conditions

Dietary ModificationBreadGastrointestinal MicrobiomeHematologic TestsBody Weight Changes

Keywords

BreadMicrobiomeBlood testsSourdough breadDietary intervention

Outcome Measures

Primary Outcomes (2)

  • Changes to glycemic control

    Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl\*h).

    One week

  • Changes to glycemic control

    Measured as blood glucose levels at wake-up (mg/dl).

    One week

Secondary Outcomes (18)

  • Changes to total cholesterol levels (mg/dl)

    One week

  • Changes to HDL cholesterol levels (mg/dl)

    One week

  • Changes to LDL cholesterol levels (mg/dl)

    One week

  • Changes to triglycerides levels (mg/dl)

    One week

  • Changes to C-Reactive Protein (CRP) levels (mg/l)

    One week

  • +13 more secondary outcomes

Other Outcomes (1)

  • Changes to gut microbiome composition and function

    One week

Study Arms (2)

Sourdough bread, white bread

OTHER

Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week

Other: Consumption of sourdough breadOther: Consumption of white bread

White bread, sourdough bread

OTHER

Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week

Other: Consumption of sourdough breadOther: Consumption of white bread

Interventions

Consumption of sourdough breadOTHER

Participants will be given sourdough bread to consume instead of other wheat products. 145g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Sourdough bread, white breadWhite bread, sourdough bread
Consumption of white breadOTHER

Participants will be given white bread to consume instead of other wheat products. 110g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Sourdough bread, white breadWhite bread, sourdough bread

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide and signed informed consent form
  • Over 18 years
  • Not in active military service
  • Ability to technically operate a glucometer

You may not qualify if:

  • Prediagnosed type I / type II diabetes mellitus
  • Pregnancy
  • Usage of antibiotics within three months prior to participation
  • Chronically active inflammatory or neoplastic disease in the three years prior to enrollment
  • Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weizmann Institute of Science

Rehovot, Israel

Location

Department of Gastroentherology

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 18, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

IL(2)